Conducting Quality Audit based on ISO 9001:2015

Transcription

1 Conducting Quality Audit based on ISO 9001:2015 FREE Professional Development Seminar Series

2 NITIN HIRANANDANI ME (MECHANICAL) ASQ CMQ/OE, OSHAD Practitioner CORPORATE TRAINER FOR LA, ASQ CMQ/OE, QUALITY MANAGEMENT, MAINTENANCE, 5S,POKA YOKE, KAIZEN ETC AUDITOR FOR IS0 9001, ISO and OHSAS CONSULTANT LEAD TRAINER, 3FOLD Education Centre

3 At the end of the class, please fill the training feedback and referral forms! Return the form at the reception!

4 Agenda About 3FOLD Education Centre 7 Quality Management Principles Brief on ISO 9001:2015 Purpose of Audit Questions for conducting quality audit based on ISO 9001:2015 Q &A Certificate collection

5 About 3FOLD Established in 2008 Branches in Abu Dhabi and Dubai. Approved by KHDA, PMI, AACE, ASQ, IMA, and CQI IRCA. An ISO 9001:2015 Certified Training Organization.

6 7 Quality Management Principles

7 PROCESS APPROACH CONTINUAL IMPROVEMENTS OF PROCESS Understandings & meeting requirements PLAN Processes in terms Of Added Value DO PDCA Cycle Continual improvements of Processes based on objective measurements ACTION Measure results of process Performance and effectiveness - Objective Measurements CHECK

8 Brief on Standard I N T R O D U C T I O N 1. Scope 2. Normative references 3. Terms and definitions 4. Context of organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement

9 ISO/TC 176/SC 2/ N1282 Plan Do Check Act 4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning 6.3 Planning of changes 7.1 Resources People Infrastructure Environment for the operation of processes Monitoring and measuring resources Organizational knowledge 8.1 Operational planning and control 8.2 Requirements of products and services 8.3 Design and development of product and services 8.4 Control of externally provided processes and services 8.5 Production and service provision 9.1 Monitoring, measurement, analysis and evaluation Customer satisfaction Analysis and evaluation 9.2 Internal audit 9.3 Management review 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 7.2 Competence 7.3 Awareness 7.4 Communication 8.6 Release of product and services 8.7 Control of non conforming outputs 7.5 Documented information 9 Date: 9

10 CLAUSES BASED ON QUALITY MANAGEMENT PRINCIPLES CUSTOMER FOCUS- 4,6,9 & 10 LEADERSHIP- 4,5,7 & 10 ENGAGEMENT OF PEOPLE- 4,5,6,7 PROCESS APPROACH- 6,8 & 9 IMPROVEMENT- 6,8,9 & 10 EVIDENCE BASED MANAGEMENT- 7,8,9 & 10 RELATIONSHIP MANAGEMENT- 4,5 & 8

11 Purpose of Management System Audit To determine conformity to requirements To determine effectiveness of the system For improvement of the system To meet regulatory requirements To meet contract requirements To gain registration for marketing and customer assurance purposes

12 Types of Audits First Party Audit Undertaken by an organization on its own quality system - to seek conformance and improvement Self-audit (Client, auditor and auditees are Internal or company appointed consultant) Second Party Audit Undertaken by an organization on an existing or potential supplier usually relating to a contract of supply Audit by an interested body (like a customer, vendor, subcontractor) Third Party Audit Audit by independent body seeking conformance to a standard such as ISO 9001 (certification/ registration body)

13 Audit - Quality Audit The Quality audit is define as a systematic & independent examination to determine whether Quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve the objectives. (1) Adequacy audit:- (System or Management audit) determine the extend to which the documented information adequately meet the requirements of standard. (2) Compliance audit:- Which seeks to establish the extent to which the documented system is implemented and observed by the work force.

14 Important Terms relating to Documented information The following terms to be considered Term Documented information Guideline Details Information and its support medium and guidelines or evidences Document stating recommendations or suggestions Record Documented information stating results achieved or providing evidence of activities performed Specification Documented information Documented information stating requirements Documented information Documentation, Manual, documented procedures, record

15 Auditing Questions

16 Auditing Questions Corrective actions Management Supervision Customer Feedback O I PEOPLE U N MATERIALS Non-conformance T P U T S METHODS ENVIRONMENT INFRASTRUCTURE Process Operators Admin Records Monitor P U T S

17 Important Auditing Elements of ISO 9001: ISO 9001 REQUIREMENTS 4 Context of organisation (24) 4.1 Context (2) 4.2 Interested parties(3) 4.3 Scope(7) 4.4 QMS and processes (12) 5 Leadership (26) 5.1 Leadership and commitment(13) 5.2 Policy(7) 5.3 Responsibilities (6)

18 Important Auditing Elements of ISO 9001: ISO 9001 REQUIREMENTS 6 Planning (27) 6.1 Actions to address risks(8) 6.2 Quality objectives(14) 6.3 Planning of changes (5) 7 Support (43) 7.1 Resources(17) 7.2 Competence(4) 7.3 Awareness (4) 7.4 Communication(5) 7.5 Documented information(13)

19 Important Auditing Elements of ISO 9001: ISO 9001 REQUIREMENTS 8 Operation (128) 8.1 Operation control(9) 8.2 Requirements(19) 8.3 Design and development (36) 8.4 External providers (21) 8.5 Production service provision(26) 8.6 Release of product and services(5) 8.7 Non conforming output(12)

20 Important Auditing Elements of ISO 9001: ISO 9001 REQUIREMENTS 9 Performance (43) 9.1 Monitoring measurement(16) 9.2 Internal audit(10) 9.3 Management review (17) 10 Improvement (18) 10.1 General(4) 10.2 Corrective action(12) 10.3 Continual improvement(2)

21 Context of organisation Internal Context Organisation Core Values Business strategic risk Addressed consideration of Strengths and Weakness that would generate opportunity or risk or Threat to the company (SWOT) Organization capability Resources Financial capability Workplace safety Employees Services

22 Context of organisation External Context Elements Political Economic External factors that may relate to Opportunity or challenges or Threats from the elements analysed (SWOT) Social Technological Legal Environmental Competitor

23 Auditing Questions Interested Parties Have you identified interested parties? Their needs and expectations Priority to meet needs and expectation of interested parties Scope and QMS Have you defined scope of QMS? Processes involved? Their interconnection? Risk and opportunity analysis

24 Auditing Questions Man Roles and responsibilities? Organisational Knowledge Competence Training need analysis Training plan Conduction of training Training effectiveness analysis, etc Machines Calibration of tools and equipment's Maintenance policy Breakdown maintenance records Preventive maintenance records Maintenance log book Production planning, etc

25 Auditing Questions Materials Approved suppliers/vendors/contractor list Procedure for the same Performance evaluation Re evaluation basis Inspection/Quality assurance of supplies, etc Customer Customer requirements analysis Validation of product or services Customer feedback Performance evaluation Customer focus Customer complaints register, etc

26 Auditing Questions Leaders Context Policy Objectives Commitment Interested parties Resources Management Appointee, if any. Internal audit programmes Conduct of audits Management Review details Non conformities Corrective actions, Improvements

27 Q & A ANY QUESTIONS?

28 Upcoming Schedule Course Title Date Frequency Timing

29 END OF SEMINAR Please Fill the FEEDBACK & REFERRAL FORM and RETURN IT to the RECEPTION.